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Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natrelle BIOCELL™ Textured 410 Implant | Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIOCELL™ Textured 410 Implant | Device | Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant | Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant. | 3 to 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects that have undergone a primary breast augmentation for aesthetic reasons with a Natrelle BIOCELL™ textured 410 cohesive implant
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux | France | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Natrelle BIOCELL™ Textured 410 Implant | Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Natrelle BIOCELL™ Textured 410 Implant | Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant | Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant. | Per Protocol: Subjects who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants 3 to 10 years prior to data collection | Posted | Number | Percentage of Subjects | 3 to 10 years |
|
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The Safety Population included all subject who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants for aesthetic reasons. The Safety Population was used to assess adverse events and serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Natrelle BIOCELL™ Textured 410 Implant | Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Breakage | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| Düsseldorf |
| Germany |
| Tel Aviv | Israel |
| Madrid | Spain |
| East Grinstead | United Kingdom |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 30 |
| 201 |
| 0 |
| 201 |
| Device Dislocation | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Capsular Contracture Associated with Breast Implant | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Device Optical Issue | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Device Damage | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Device Deployment Issue | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Device Expulsion | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Impaired Healing | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Implant Site Reaction | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Nipple Disorder | Reproductive system and breast disorders | MedDRA version 17.1 | Systematic Assessment |
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| Breast Cancer Female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Systematic Assessment |
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| Breast Pain | Reproductive system and breast disorders | MedDRA version 17.1 | Non-systematic Assessment |
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| Device Issue | General disorders | MedDRA version 17.1 | Systematic Assessment |
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| Post Procedural Haematoma | Injury, poisoning and procedural complications | MedDRA version 17.1 | Systematic Assessment |
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| Scar Excision | Surgical and medical procedures | MedDRA version 17.1 | Systematic Assessment |
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| Seroma | Injury, poisoning and procedural complications | MedDRA version 17.1 | Systematic Assessment |
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| Surgery | Surgical and medical procedures | MedDRA version 17.1 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.